Trial · NCT01296672

3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer

NCT01296672, Phase 4, Completed, The University of Texas Health Science Center at San Antonio; results first posted 2017-09-08

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. 3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer. Trials, record NCT01296672. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01296672

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer
NCT number: NCT01296672
Status: Completed
Phases: Phase 4
Enrollment: 383 participants, actual
Lead sponsor: The University of Texas Health Science Center at San Antonio
Conditions: Prostate Cancer
Interventions: Finasteride, Placebo
First posted: 2011-02-15
Last updated: 2017-10-06
Results first posted: 2017-09-08

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pre/Post Ratio PSA Area Under the Curve (AUC)	Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months	Pre/Post Ratio prediction area under the receiver operating characteristics curve (AUC) for subjects taking finasteride 5mg every day for 3 months. Measurements of PSA are measured from Baseline until 3 months.
Secondary	PCA3 (Prostate Cancer Antigen 3)Score AUC	Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day	Area under the Receiver Operating Characteristic Curve (ROC-AUC) of the PCA3 (Prostate Cancer Antigen 3) to detect difference in PSA decline between cases and controls (non-cases)
Secondary	T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC	Reported at 90 days: assessed at baseline, 30 days, 60 days, and 90 days	Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score to Predict the Risk of Prostate Cancer

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Pre/Post Ratio PSA Area Under the Curve (AUC)	Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months	Patients with biopsy	Ratio	NUMBER
SECONDARY	PCA3 (Prostate Cancer Antigen 3)Score AUC	Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day	Receiving biopsy	ratio	NUMBER
SECONDARY	T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC	Reported at 90 days: assessed at baseline, 30 days, 60 days, and 90 days	Receiving biopsy	Ratio	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Pre/Post Ratio PSA Area Under the Curve (AUC)	Finasteride	0.57	95% Confidence Interval 0.45 to 0.6	Ratio
Pre/Post Ratio PSA Area Under the Curve (AUC)	Placebo	0.61	95% Confidence Interval 0.46 to 0.76	Ratio
PCA3 (Prostate Cancer Antigen 3)Score AUC	Finasteride	0.65	95% Confidence Interval 0.58 to 0.72	ratio
PCA3 (Prostate Cancer Antigen 3)Score AUC	Placebo	0.84	95% Confidence Interval 0.73 to 0.96	ratio
T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC	Finasteride	0.62	95% Confidence Interval 0.55 to 0.69	Ratio
T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC	Placebo	0.62	95% Confidence Interval 0.47 to 0.76	Ratio

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Finasteride	306
Overall Study	STARTED	Placebo	77
Overall Study	COMPLETED	Finasteride	233
Overall Study	COMPLETED	Placebo	59
Overall Study	NOT COMPLETED	Finasteride	73
Overall Study	NOT COMPLETED	Placebo	18

Source ClinicalTrials.gov

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Rash	Skin and subcutaneous tissue disorders	Finasteride	4	306	4
other	Rash	Skin and subcutaneous tissue disorders	Placebo	0	77	0
other	Decreased libido	Reproductive system and breast disorders	Finasteride	3	306	4
other	Decreased libido	Reproductive system and breast disorders	Placebo	0	77	0
other	Cough	Respiratory, thoracic and mediastinal disorders	Finasteride	0	306	0
other	Cough	Respiratory, thoracic and mediastinal disorders	Placebo	1	77	1
other	Dehydration	Gastrointestinal disorders	Finasteride	0	306	0
other	Dehydration	Gastrointestinal disorders	Placebo	1	77	1
other	Itch	Skin and subcutaneous tissue disorders	Finasteride	1	306	1
other	Itch	Skin and subcutaneous tissue disorders	Placebo	1	77	1

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Finasteride	0	306
Total, all-cause mortality	Placebo	0	77
Total, other adverse events	Finasteride	7	306
Total, other adverse events	Placebo	6	77
Total, serious adverse events	Finasteride	3	306
Total, serious adverse events	Placebo	1	77

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30300367	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01CA138627	Improving prostate biopsy efficiency: The finasteride challenge test	HERNANDEZ, JAVIER; LEACH, ROBIN JEAN	UNIVERSITY OF TEXAS HLTH SCIENCE CENTER	NATIONAL CANCER INSTITUTE	2010 to 2014

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Finasteride vs Placebo: deaths from any cause	Trial comparisons
Finasteride vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01296672

GET https://conductscience.org/api/trials/v1/NCT01296672/events?page=2

API reference For AI assistants